ISO 13485 training in Malaysia, taught for medical devices and paid from your HRD Corp levy.
A 1-day awareness course for the whole team and a 2-day internal auditor course for the people who will run your audits. In-house at your factory or online, built around Malaysian requirements (Act 737, the MDA manufacturer licence, CAB audits), and taught by the consultants who implement ISO 13485 for a living.
Short answer: we run two ISO 13485:2016 courses for medical device companies in Malaysia: awareness (1 day) and internal auditor (2 days), in-house or online. Both are HRD Corp claimable: the course fee is paid from your HRD Corp levy, within HRD Corp’s cap of RM10,500 per group per day for in-house courses. If you also want the system built, our ISO 13485 implementation is RM7,500 our fee.
ISO 13485:2016 Awareness and Requirements
Who should attend: Manufacturers, own-brand companies and contract manufacturers; all staff who work inside the QMS.
- Why ISO 13485 matters in Malaysia: the manufacturer licence, MDA registration, MDSAP, CE and FDA
- Clauses 4 to 8 in plain language: documentation, management responsibility, resources, product realisation, measurement and improvement
- Risk management across the life cycle and how ISO 14971 connects
- Records an auditor will ask for, and the common nonconformities
ISO 13485:2016 Internal Auditor
Who should attend: QA/RA staff and managers who will run the internal audit programme.
- Audit principles and the audit programme (ISO 19011 approach)
- Planning an audit, building checklists from the clauses and your procedures
- Conducting the audit: sampling, interviewing, collecting objective evidence
- Writing nonconformities, reporting, corrective action and follow-up
- Practical audit exercise on medical device scenarios, with an assessment
Why train with a medical device consultancy, not a general ISO trainer
- Examples come from medical devices: design files, sterilisation, complaint and vigilance records, CAPA after an MDA query, not from a generic factory
- The Malaysian layer is included: the manufacturer licence under Act 737, MDA registration, the CSDT, and what the CAB looks for
- The trainers implement ISO 13485 for manufacturers and hold our own MDA establishment licence; they teach what they audit and fix
- The same team can then build your system, so the course is the first week of the project, not a separate event
Training + implementation package
| Part | What it covers | Who pays |
|---|---|---|
| Training | ISO 13485 awareness (1 day) + internal auditor (2 days) | Your HRD Corp levy, within the HRD Corp cap |
| Implementation | QMS build, implementation, internal audit support, audit-day support, MDA manufacturer licence application | RM7,500 our fee (year 1) |
| Certification and licence | Certification body audit; MDA manufacturer licence | Paid direct: RM7,500 and RM4,250 (RM250 + RM4,000) |
| Years 2 and 3 | Surveillance support | RM4,000/yr our fee; certification body RM5,000/yr direct |
Training is invoiced to HRD Corp by MedTech Advisory PLT; consultancy is invoiced by AA Alive Sdn Bhd. Consultancy payment plans from RM1,500 a month. Full details of the implementation on our ISO 13485 consulting page; for the certification steps themselves see ISO 13485 certification in Malaysia on our sister site. Setting up a new plant or own-brand range? Start with our manufacturing consultant page.
How the HRD Corp claim works
- We send a quotation with the course details and the claimable amount.
- You apply for the grant in e-TRiS at least one day before the course (no levy arrears).
- We run the course; trainees sign the daily attendance (T3) form and attend at least 75% of the hours.
- A manager approves the JD14 declaration; we invoice HRD Corp, which debits the fee from your levy.
Limits, allowances and the full process are on HRD Corp claimable training.
Adakah latihan ISO 13485 boleh dituntut HRD Corp?
Ya. Kursus kesedaran ISO 13485 (1 hari) dan juruaudit dalaman ISO 13485 (2 hari) kami boleh dibayar daripada levi HRD Corp melalui MedTech Advisory PLT, penyedia latihan berdaftar HRD Corp. Had yuran kursus dalaman ialah RM10,500 bagi setiap kumpulan sehari. Pelaksanaan ISO 13485 ialah yuran perundingan kami RM7,500. WhatsApp 010-206 2070.
Frequently asked questions
Is your ISO 13485 training HRD Corp claimable?
Which course do we need, awareness or internal auditor?
Does the internal auditor course make us a certified ISO 13485 lead auditor?
Can you run it at our factory?
Can HRD Corp pay for the ISO 13485 certification too?
Do you also train on GDPMD?
Train the team, then build the system
Tell us the team size and your ISO 13485 status. You get dates, the claimable amount and, if you want it, the implementation quote.